Back to resultsGabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis
Primary Purpose
Liver Cirrhosis
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Gabapentin
Calcium Carbonate
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- liver cirrhosis patients
Exclusion Criteria:
- allergy to gapabentin.
- pregnancy and lactation. Renal failure.
Sites / Locations
- Tanta university - faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Gabapentin
PLacebo
Arm Description
Gabapentin twice daily
Calcium carbonate twice daily
Outcomes
Primary Outcome Measures
Number of muscle cramps
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02642484
Brief Title
Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis
Official Title
Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly effective drug.
Quinine was suggested for treatment of patients with muscle cramps in patients with liver cirrhosis. However, thrombocytopenia, cardiac arrhythmias and cinchonism are serious side effects.
Detailed Description
• The aim of the study was to assess the efficacy and safety of Gabapentin in the treatment of muscle cramps in patients with liver cirrhosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
Gabapentin twice daily
Arm Title
PLacebo
Arm Type
Placebo Comparator
Arm Description
Calcium carbonate twice daily
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Gaptin
Intervention Description
Gapapentin twice daily
Intervention Type
Drug
Intervention Name(s)
Calcium Carbonate
Other Intervention Name(s)
Calcitron
Intervention Description
calcium carbonate twice daily
Primary Outcome Measure Information:
Title
Number of muscle cramps
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
liver cirrhosis patients
Exclusion Criteria:
allergy to gapabentin.
pregnancy and lactation. Renal failure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief M. Abd-Elsalam, Consultant
Phone
00201095159522
Email
sherif_tropical@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherief M. Abd-Elsalam, Consultant
Organizational Affiliation
Hepatology and gastroenterology dept.-Tanta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
A. K. Singal, Professor
Organizational Affiliation
Division of Gastroenterology and Hepatology, UAB, Birmingham, AL, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Walaa A. Elkhalawany, Lecturer
Organizational Affiliation
Hepatology and gastroenterology dept.-Tanta
Official's Role
Study Director
Facility Information:
Facility Name
Tanta university - faculty of medicine
City
Tanta
State/Province
Elgharbia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis
We'll reach out to this number within 24 hrs